A Randomized, Double-Blind Study of MKC-442 Combined With Viracept in Patients Who Are Epivir + Retrovir Experienced and Are Protease Inhibitor- and Non-Nucleoside Reverse Transcriptase Inhibitor-Naive
Completed · Not applicable
Conditions studied: HIV Infections
In brief
To compare the proportion of patients whose plasma HIV-1 RNA level falls and remains below the limit of quantification by the Roche Amplicor Monitor (400 copies/ml)\[AS PER AMENDMENT 8/4/98: 50 copies/ml\] between weeks 0 and 24. To determine the short-term safety and tolerability of MKC-442 plus nelfinavir (Viracept) plus dual nucleoside analogs. To determine the time to viral failure and time to tolerability failure through Week 48 of therapy.
Key facts
- Study ID
- NCT00002215
- Run by
- Triangle Pharmaceuticals
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Concurrent Medication:
- Required:
- At least 1 different nucleoside analog, e.g., 3TC, d4T, or ddI (excluding zidovudine).
- Allowed:
- Chemoprophylaxis for Pneumocystis carinii pneumonia.
- Short courses (less than 21 days) of acyclovir for acute treatment.
- Recombinant erythropoietin or G-CSF for Grade 3 or greater anemia and neutropenia, respectively.
- Allowed only with caution and close patient monitoring:
- Ketoconazole, fluconazole, itraconazole, and grapefruit juice.
- Medications metabolized by cytochrome P450.
- Oral contraceptives, contraceptive implants such as Norplant, or injection-type contraceptives such as Depo-Provera only if not sole method of contraception.
- Patients may have:
- HIV-1 RNA greater than 10,000.
- No active AIDS-defining illnesses.
- Prior experience with 2 nucleoside analogues and able to switch to at least 1 different non-nucleoside analog, e.g., lamivudine (3TC), stavudine (d4T), or didanosine (ddI) with HIV-1 RNA 10,000 copies/ml or less. [AS PER:
- 8/4/98 AMENDMENT].
- [AS PER AMENDMENT 8/4/98:
- Nucleoside analog-naive patients must have HIV-1 RNA greater than 50,000 copies/ml.].
- Prior Medication:
- Allowed:
- Treatment with 2 nucleoside analogs. Note:
- able to switch to at least 1 different nucleoside analog e.g., lamivudine (3TC), stavudine (d4T), or didanosine (ddI), while on study [AS PER AMENDMENT 8/4/98].
You may not qualify if…
- Co-existing Condition:
- Patients with any of the following symptoms or conditions are excluded:
- Active AIDS-defining illnesses.
- Malabsorption syndrome or severe chronic diarrhea within 30 days of entry, or inability to consume adequate oral intake due to chronic nausea, emesis, or abdominal or esophageal discomfort. [AS PER AMENDMENT 8/4/98].
- Inadequately controlled seizure disorder [AS PER AMENDMENT 8/4/98].
- Any intercurrent illness that could affect viral load determination [AS PER AMENDMENT 8/4/98].
- Concurrent Medication:
- Excluded:
- Zidovudine.
- Immunomodulators (e.g., systemic corticosteroids, interleukin-2, or interferons). [AS PER AMENDMENT 8/4/98].
- Rifampin, rifabutin, phenobarbital, and hydantoin.
- Amiodarone, quinidine, astemizole, terfenadine, ergot derivatives, midazolam, triazolam, and cisapride.
- Neurotoxic agents (e.g., vincristine, thalidomide). [AS PER AMENDMENT 8/4/98].
- Patients with the following prior conditions are excluded:
- History of acute or chronic pancreatitis.
- History of > grade 2 peripheral neuropathy.
- Patients with an acute and clinically significant medical event within 30 days of screening.
- Prior Medication:
- Excluded:
- Protease inhibitors.
- Non-nucleoside reverse transcriptase inhibitors.
- Excluded within 30 days of study drug administration:
- Immunomodulators (e.g., systemic corticosteroids, interleukin-2, or interferons). [AS PER AMENDMENT 8/4/98].
- Rifampin, rifabutin, phenobarbital, and hydantoin.
- Amiodarone, quinidine, astemizole, terfenadine, ergot derivatives, midazolam, triazolam, and cisapride.
Where it is running
- Anderson Clinical Research — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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